Learn how to grow and use medicinal herbs, adaptogen herbs such as Jiaogulan, and herbal medicine to create vibrant health and an enriched life style. There are a number of herbs you can grown at home which is fun and great for your health.
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Sunday, August 12, 2012

Well at 61 (myself) and 66 (my husband) we thought long and hard about adopting two new kids into the family. We are seniors by age and so it was a hard decision....at this time of our life. After all we have grand children. But we decided that since these two kids were out of a home.....and needed someone to take them in...it seemed we were picked to take on these new responsibilities.

So meet our two new kids....goat kids ......that is. My children all think I am crazy but that is ok. They can have their quiet houses..their city life......and I will take the sounds of chickens laying eggs, the ducks going on patrol and eating all the bugs and weeds....and these new kids. They are a lot of work so don't take on goat kids without much consideration. They are cute but can get ornery. I have had them before in 1999 so am not a newbie with goats.

Meet Mollie and Max

Max on the left and Mollie on the Right.....3 month old Nubian cross goatlings

I write such serious articles most of the time....I thought I would throw in some humor for a change. These little guys came from a woman who came into hard times and could not pay for feed. She just wanted a good home for them.....Mollie and Max who has been altered. Understand that when you separate them from mom it is rough. Goatlings let out horrible cries like you are killing them slowly that can be heard for blocks. Make sure you have understanding neighbors and legal zoning laws. I took them over to meet the neighbors so that their noisy presence would be more tolerated. This only lasted a day..Thank God.

These two are already leash trained. ...Taking Exercise to A NEW LEVEL
I decided that I would train them early so already, two days later, they have learned that a leash takes them out of their pen and for a run. Twice a day, the goats and dogs with me leading go on a walk about on
the acre. They get to eat a few weeds, explore some, and run. They need
to exercise their legs while we expand their pen. Leash training works
at 30 pounds not 100 pounds which will be their size full grown. They
are like big dogs...train them early. They already like Moringa leaves
too. They have been easier to train than some dogs I have had.

Why have goats?

Their manure is one of the best for you garden and does not have to be aged. It can be directly added to worm beds. They eat your weeds if you direct them too. They will prune your trees if your guide them. They must be guided or they will eat your trees completely and your garden soooooo....you must contain their activity on your property. Good fences is a must.

Great quality organic milk:

Later on the doe will be bred and give milk. Goat's milk is good for you. Most people can drink goat's milk even when they cannot drink cow's milk. It is the closest thing to breast milk and is healing to the stomach. When fresh and when it comes from goats fed grain, the milk is great.

These two finish out my plan for self sufficiency. The milk will be made into cheese and yogurt as well.

I have had several reader emails on this subject so here is the answer.

Nothing is simple in the US. Moringa leaf production must be grown, picked, washed, dried, and packaged under regulations........

#1 You must have many acres of land with good drainage and water. It must be in an area that does not freeze to grow it year round. That is found in only a few areas of the United States such as Florida, Hawaii, and San Diego -LA areas. Most of the other states get freezes which kills the Moringa Tree. It grows best at sea level to 1500 feet which is only found in the states above too. So Moringa is an Asian tree that needs specific climate requirements to grow well. These climate requirements are only found in a few areas

We moved to Nevada which is 4300 feet, no humidity, horrible winds, and just not a climate zone where you can plant them outdoors. My trees are kept in the house in 33 gal trash cans on wheels with a hard saucer to catch drainage. I have a few that are now about 4 to 5 feet high. They will stay in the house when winter hits in two months. We get temps down to 0 some years here and snow. So here in Nevada you grown and maintain them in the house or greenhouse.

#2 You must have a hundred acres of trees at least to have enough to sell. It takes a lot of leaves, when dried, to make up a pound. Most areas of the US because of water costs and regulations, are too expensive to grow enough trees to sell. Most growers have to buy product from other countries to supplement what they cannot produce themselves. There are a few plantations in production now, that in the future may provide product in enough quanity to supply US buyers.

#3 Let us say, you have the Moringa trees growing in your area...enough to begin selling the leaves and pods.

Understand, that the pods contain the seeds you need to keep planting your own Moringa trees for the future. Most growers do not sell their own seed, because they use it to replant. It takes several years of production to have enough seeds to sell.

Once You Cut the Leaves...........Acres of Rules and Regulations

Once you cut the leaves off the tree you are subject to pages of rules and regulations by the local health department, the FDA, and your state's local agricultural laws. You cannot just sell the leaves.

You are supposed to have a business license, a nursery license, health certificate, fire inspection, inspections by the local agricultural agency to make sure your trees are free of disease and bugs. Once you cut the leaves for resale, you must get a health permit for your business and where you hold the leaves after picking them. It cannot be at your home.

You must rent a specific building to house the product that is inspected by the health dept. It must pass many rules for cleanliness, temperature, and much more. You and your employees must have a health permit to handle the product. The reason for that is so that they know your employees do not have TB or other diseases that can be spread by handling the product. They must ensure you are using the proper steps such as hand washing and gloves, so that customers do not get sick.

You must pass inspections on your companies procedures involving washing and drying the leaves properly. This is where the product may become contaminated with mold, mildew or bacteria. If the leaves are not dryed quickly at low heat, they will and often do become contaminated.

This is an extremely critical part of Moringa or herb processing that can make a nutritious product into a contaminated-nutritionally empty product. How is the dried product stored? Is the room and equipment clean? There are many more factors to consider at this point.

You have two choices:

Ship the product to a FDA -GMP compliant lab to test the product and bottle it within the law

or do it yourself.

Today by the GMP law, small companies must adhere to the GMP rules just like the big companies.

It can cost $50,000 and more to comply to these rules. So most small businesses cannot afford that.

They either are operating under the laws below or they send it to a lab that is certified by the state to package the raw product. There are thousands of small companies right now, still operating under the radar of the GMP laws. The inspectors have not gotten to them yet.

Read some of this below copied from the FDA site: You will have a headache with just this much below. That is why herbs and supplements cost more there than from foreign countries. You must research the company that manufactures the product to know if it is GMP compliant. The bottle will not tell you. You must research the company to know what tests they perform on their products to ensure their safety and yours. The bottle gives you only certain information.....not enough to know how good the product is.

I will sign off here but please read the GMP part below....you need to understand what your herb product goes through and why it costs so much. The cheap products often have just the min testing done or they may be one of the companies that are operating at this point under the GMP radar.

Guidance for Industry: Current Good
Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding
Operations for Dietary Supplements; Small Entity Compliance Guide

You may submit either electronic or written comments regarding this guidance at any time. Submit electronic comments to http://www.regulations.gov.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. All comments should be identified with
the docket number listed in the notice of availability that publishes in
the Federal Register.

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
Small Entity Compliance Guide

This
guidance represents the Food and Drug Administration's (FDA's) current
thinking on this topic. It does not create or confer any rights for or
on any person and does not operate to bind FDA or the public. You can
use an alternative approach if the approach satisfies the requirements
of the applicable statutes and regulations. If you want to discuss an
alternative approach, contact the FDA staff responsible for implementing
this guidance. If you cannot identify the appropriate FDA staff, call
the telephone number listed on the title page of this guidance.

I. Introduction

On June 25, 2007, FDA published in the Federal Register a
final rule that established a regulation (21 CFR part 111) entitled
Current Good Manufacturing Practice (CGMP) In Manufacturing, Packaging,
Labeling, Or Holding Operations For Dietary Supplements (72 FR 34752).
The Dietary Supplement (DS) CGMP rule in 21 CFR part 111 (“the DS CGMP
rule”) requires persons who manufacture, package, label, or hold a
dietary supplement to establish and follow current good manufacturing
practice to ensure the quality of the dietary supplement and to ensure
that the dietary supplement is packaged and labeled as specified in the
master manufacturing record.
In the same issue of the Federal Register (72 FR 34959), FDA
also issued an interim final rule (the identity testing interim final
rule) setting forth a procedure for requesting an exemption from a
requirement of the DS CGMP rule for the manufacturer to conduct at least
one appropriate test or examination to verify the identity of any
dietary ingredient that is a component of a dietary supplement. The
provisions of the identity testing interim final rule have the full
force of law, but FDA provided a 90-day comment period on those
provisions through September 24, 2007. On September 17, 2007, FDA
published a notice in the Federal Register to extend the comment period to October 24, 2007.
The DS CGMP rule and the identity testing interim final rule were
effective as of August 24, 2007. The compliance dates are described
below.
FDA has prepared this Small Entity Compliance Guide in accordance
with section 212 of the Small Business Regulatory Enforcement Fairness
Act (Public Law 104-121). This guidance document restates in plain
language the legal requirements set forth in the DS CGMP rule (21 CFR
part 111). The DS CGMP rule is binding and has the full force and effect
of law.
FDA's guidance documents, including this guidance, do not establish
legally enforceable responsibilities. Instead, guidances describe the
Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. Discussion

Compliance Dates for the Dietary Supplement Current Good Manufacturing Practice Rule (DS CGMP Rule) and the Interim Final Rule

What were the compliance dates for the DS CGMP rule?
As shown in Table 1, the compliance dates were based on how many full-time equivalent employees (FTEs) you employ.

Table 1
Compliance Dates Based on the Size of Your Organization

If you employ …

The DS CGMP rule required you to comply by …

500 or more FTEs

June 25, 2008

At least 20 but fewer than 500 FTEs

June 25, 2009

Fewer than 20 FTEs

June 25, 2010

Organization of the DS CGMP Rule

How is the DS CGMP rule organized?
The DS CGMP rule is organized as a series of “subparts,”
which each cover a different aspect of current good manufacturing
practice. We list these subparts in Table 2.

Table 2
Subparts of the DS CGMP Rule

Subpart

Subject of Subpart

A

General Provisions (including coverage and definitions)

B

Personnel

C

Physical Plant and Grounds

D

Equipment and Utensils

E

Requirements to Establish a Production and Process Control System

F

Production and Process Control System: Requirements for Quality Control

G

Production and Process Control System:
Requirements for Components, Packaging, Labels and for Product that You
Receive for Packaging or Labeling as a Dietary Supplement

H

Production and Process Control System: Requirements for the Master Manufacturing Record

I

Production and Process Control System: Requirements for the Batch Production Record

J

Production and Process Control System: Requirements for Laboratory Operations

K

Production and Process Control System: Requirements for Manufacturing Operations

L

Production and Process Control System: Requirements for Packaging and Labeling Operations

M

Holding and Distributing

N

Returned Dietary Supplements

O

Product Complaints

P

Records and Recordkeeping

III. Subpart A – General Provisions

Coverage of the DS CGMP Rule

Who is subject to the DS CGMP rule?
You are subject to the DS CGMP rule if you manufacture, package, label, or hold a dietary supplement.
(21 CFR 111.1(a))
In our answers to questions in sections III.A, III.B, III.C
and XIX of this document, we address some specific examples of firms who
do, or do not, fall within the coverage of the DS CGMP rule.

Am I subject to the DS CGMP rule if I am a foreign firm?
Yes. The DS CGMP rule applies to you if you manufacture,
package, label, or hold a dietary supplement imported or offered for
import in any State or Territory of the United States, the District of
Columbia, or the Commonwealth of Puerto Rico.
(21 CFR 111.1(a)(2))

Am I subject to the DS CGMP rule if my product is sold only within my state?
You may be subject to the DS CGMP rule for products sold only
within your state. FDA may consider its jurisdiction over such products
under the Public Health Service Act, the Federal Food, Drug, and
Cosmetic Act, or both, depending on the circumstances of the situation.
(72 FR 34752 at 34785)

Am I subject to the holding requirements established
in the DS CGMP rule if I am a retailer who is holding dietary
supplements at a retail establishment for the sole purpose of direct
retail sale to individual consumers?
No. Importantly, a retail establishment does not include a
warehouse or other storage facility for a retailer or a warehouse or
other storage facility that sells directly to individual consumers.
(21 CFR 111.1(b); 72 FR 34792)

Am I subject to the holding requirements established
in the DS CGMP rule if I am a retailer who operates a warehouse or
storage facility?
Yes. The “retail exemption” does not apply to you, because a
retail establishment does not include a warehouse or other storage
facility for a retailer or a warehouse or other storage facility that
sells directly to individual consumers (21 CFR 111.1(b); 72 FR 34752 at
34792).

Do the requirements of the DS CGMP rule apply to all
types of dietary supplements (e.g., for botanical dietary supplements
and for vitamin/mineral dietary supplements)?"

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Paid Endorsement Disclosure: In order for me to support my blogging activities, I may receive monetary compensation or other types of remuneration for my endorsement, remuneration, testimonial and or links to any products or services from this blog. Greatly Blessed Medicinal Herbs is also a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to amazon.com

I am also a independent distributor for Nature's Sunshine Herb and Vitamins for which I receive income from sales.

Medical Disclaimer:

I am not a doctor and the statements and products promoted on this blog have not been evaluated by the FDA or AMA. Any products or blog material mentioned in my blogs are not intended to diagnose, treat , cure, or prevent any disease. I cannot give medical advice by phone or email. It is suggested that you should get advice from your doctor before you add any herb or supplement to your diet.

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